Compounds of Formula I:

are antiepileptic compounds that are known to be highly effective anticonvulsants in animal tests. These compounds are set forth in U.S. Pat. Nos. 4,513,006 and 6,071,537. One of these compounds 2,3:4,5-bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate [alternatively, 2,3:4,5-di-0-isopropylidene-β-D-fructopyranose sulfamate], which is known under the drug name topiramate, has been demonstrated in clinical trials to be effective as adjunctive therapy or on its own for treating human epilepsy including primary generalized tonic-clonic seizures (also known as grand mal seizures, which involve the entire body) and partial onset seizures (which generally involve only a single part of the brain), for which it has been approved by the United States Food and Drug Administration. Also, topiramate is prescribed for prevention of migraine headaches. It generally understood to work by dose-dependent inhibition of voltage-gated sodium and calcium channels, augmentation of GABA-induced chloride flux, inhibition of glutamate-related excitatory neurotransmission, and inhibition of carbonic anhydrase (see, e.g., U.S. Pat. No. 7,238,470). It is sold under the brand name Topamax® and is also available in generic form from a number of manufacturers. The chemical structure and functions of topiramate can generally be understood with reference to U.S. Pat. Nos. 6,071,537; 6,191,117; 7,351,695; and 7,390,505, each of which is incorporated by reference in its entirety with specific reference to data regarding treatment for weight-loss and weight-maintenance, as well with specific reference to the chemical structures and modes of action disclosed therein.
Obesity in humans is commonly measured by the BMI (body mass index) which is the weight in kilograms divided by the height in meters squared. The degree of obesity is determined by comparisons against standard deviations above the means for males and females. Obesity is a contributing factor to mortality, particularly in developed countries and in populations of developing countries, where consumed caloric content exceeds calories burned by activity (which may be affected by genetic and other factors). Topiramate has been recognized as effective in treating obesity at dosages of 25 mg and greater, taken perorally by itself, typically at dosages of 100-200 mg when taken alone. Topiramate has also been recognized as effective in treating obesity when administered at dosages of 23 mg or greater with phentermine (or another sympathomimetic agent or other material), as set forth in U.S. Pat. Nos. 7,109,198; 7,328,470; 8,227,476; 8,580,298; 8,580,299; 8,785,458; 8, 895,057; and 9,011,905, each of which is incorporated by reference in its entirety with specific reference to data regarding treatment for weight-loss and weight-maintenance, as well with specific reference to the chemical structures and modes of action disclosed therein.
In view of certain side effects associated with topiramate, it may be desirable to provide a mode of delivery that is effective for treating obesity and/or enhancing weight-loss or weight-maintenance, but at a lower dosage than known treatment regimens.